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Dosage form: lotion
Ingredients: HYDROCORTISONE 1g in 100.65mL
Labeler: Qualitest Pharmaceuticals Inc.
NDC Code: 0603-7784

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Hydrocortisone Lotion 1%

WARNINGS: For external use only. Avoid contact with eyes. If conditions worsen, or if symptoms persist for more than 1 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a physician. Do not use for the treatment of diaper rash. Consult a physician

USUAL DOSAGE: Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a physician.
INDICATIONS: For !he temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis or psoriasis. Other uses of this product should be only under the advice or supervision of a doctor.

NDC 0603-7784-54

Anti-itch lotion

Each gram contains 10 mg of Hydrocortisone in a water washable lotion base of: Water, Propylene Glycol, TEA Stearate, Mineral Oil, Glyceryl Stearate SE, Acetylated Lanolin Alcohol, Cetyl Acetate, Lanolin Alcohol, Choleth-24, Ceteth-24, Carbomer 934, Methylparaben, Propylparaben, Diazolidinyl Urea.
4 fl oz.(118.3 ml)


hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-7784
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
#Item CodePackage Description
1NDC:0603-7784-5412 BOTTLE (BOTTLE) in 1 CASE
1118.3 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/1998
Labeler - Qualitest Pharmaceuticals Inc. (011103059)
Registrant - Harmony Labs, Inc. (105803274)
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 04/2010
Qualitest Pharmaceuticals Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.